GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
Report
- Report Number
- 3007284313-2025-04197
- Event Type
- Injury
- Date Received
- August 19, 2025
- Date of Event
- April 12, 2025
- Report Date
- September 25, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIR
- PMA / PMN Number
- P040027
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B2: UPDATED SUMMARY. H3: NO DEVICE REMAINS IMPLANTED. H6 ADDED CODE C20 INSTEAD OF C21 AND D15 INSTEAD OF D16. A UNIQUE DEVICE IDENTIFICATION NUMBER WAS NOT PROVIDED, THEREFORE THE MANUFACTURING DATE AND/OR PRODUCTION DETAILS CANNOT BE DETERMINED. NEITHER IMAGES ENABLING DIRECT ASSESSMENT OF PRODUCT PERFORMANCE NOR THE PRODUCT ITSELF, WERE RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED TO GORE, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE ESTABLISHED.
A1: NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. A3A: MALE SELECTED AS MAJORITY OF SUBJECTS IN LITERATURE ARE MALE. H3: DEVICE NOT AVAILABLE FOR EVALUATION. LITERATURE ARTICLE ATTACHED. FURTHER INVESTIGATION IS BEING CONDUCTED AND WILL BE REPORTED IN THE FINAL REPORT. FURTHER INFORMATION WAS REQUESTED BUT NOT PROVIDED YET. AN IMAGE INVESTIGATION WILL BE CONDUCTED IF IMAGES ARE MADE AVAILABLE. AN ENGINEERING INVESTIGATION WILL BE PERFORMED IF THE DEVICE IS RETURNED. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
THE FOLLOWING ARTICLE WAS REVIEWED: BANARES, R., ET AL. (2025). FEASIBILITY, SAFETY AND EFFICACY OF TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT FOR THE MANAGEMENT OF PORTAL VEIN THROMBOSIS IN CIRRHOSIS. JOURNAL OF CLINICAL AND EXPERIMENTAL HEPATOLOGY, 15(5), 102580. HTTPS://DOI.ORG/10.1016/J.JCEH.2025.102580. THIS WAS A SINGLE-CENTRE, RETROSPECTIVE REVIEW OF CIRRHOTIC PATIENTS UNDERGOING TOTAL TRANS JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) CREATION SOLELY FOR PORTAL VEIN RECANALIZATION BETWEEN JANUARY 2013 AND MARCH 2023. ALL PROCEDURES USED GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION (VCX DEVICE), EMPLOYED SINCE JULY 2017. THIRTY PATIENTS WERE INCLUDED (21 MALE, 9 FEMALE) WITH A MEDIAN AGE OF 56 YEARS (IQR 52¿59). ACCORDING TO THE ARTICLE, ENDOTIPSITIS HAD OCCURRED IN ONE PATIENT (3.3%). THE ENDOTIPSITIS WAS SUCCESSFULLY TREATED WITH LONG-TERM ANTIBIOTIC THERAPY. NO OTHER INFORMATION WAS PROVIDED.
THE FOLLOWING ARTICLE WAS REVIEWED: BANARES, R., ET AL. (2025). FEASIBILITY, SAFETY AND EFFICACY OF TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT FOR THE MANAGEMENT OF PORTAL VEIN THROMBOSIS IN CIRRHOSIS. JOURNAL OF CLINICAL AND EXPERIMENTAL HEPATOLOGY, 15(5), 102580. HTTPS://DOI.ORG/10.1016/J.JCEH.2025.102580. THIS WAS A SINGLE-CENTRE, RETROSPECTIVE REVIEW OF CIRRHOTIC PATIENTS UNDERGOING TOTAL TRANS JUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) CREATION SOLELY FOR PORTAL VEIN RECANALIZATION BETWEEN JANUARY 2013 AND MARCH 2023. ALL PROCEDURES USED GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION (VCX DEVICE), EMPLOYED SINCE JULY 2017. THIRTY PATIENTS WERE INCLUDED (21 MALE, 9 FEMALE) WITH A MEDIAN AGE OF 56 YEARS (IQR 52¿59). ACCORDING TO THE ARTICLE, CONGESTIVE HEART FAILURE IN ONE PATIENT (3.3%) OCCURRED. IT WAS FURTHER REPORTED THAT ENDOTIPSITIS HAD OCCURRED IN ONE PATIENT (3.3%). DEVICE-RELATED DYSFUNCTION OCCURRED IN 5 PATIENTS (17%), CONFIRMED BY HEMODYNAMIC AND VENOGRAPHIC ASSESSMENT, WITH A MEDIAN ONSET OF 5 MONTHS (IQR 2¿18) ¿ MOST WITHIN THE FIRST 6 MONTHS. THREE CASES SHOWED REDUCED STENT DIAMETER, TREATED WITH ANGIOPLASTY (ONE NEEDING AN ADDITIONAL STENT), WHILE TWO CASES HAD COMPLETE STENT THROMBOSIS, MANAGED WITH THROMBOLYSIS OR MECHANICAL THROMBECTOMY AND COAXIAL STENTING. THE PROBABILITY OF REMAINING FREE OF DYSFUNCTION WAS 84% AT 6 AND 12 MONTHS, AND 79% AT 24 MONTHS. OVERALL, THE STUDY CONCLUDES THAT VCX STENT¿BASED TIPS FOR PORTAL VEIN RECANALIZATION IN CIRRHOSIS IS FEASIBLE, EFFECTIVE, AND SAFE, WITH OUTCOMES COMPARABLE TO TIPS PLACED FOR STANDARD INDICATIONS, THOUGH EARLY SURVEILLANCE IS RECOMMENDED DUE TO THE HIGHER DYSFUNCTION RISK IN THE FIRST 6 MONTHS. FOR COMPLAINT (B)(4): -OTHER AND PATIENT SYMPTOM CODE 2203-A: -OTHER HAVE BEEN CHOSEN FOR THE REPORTED CONGESTIVE HEART FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1520478 | GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS | MIR | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Required Intervention |